In the latest news, the State Food and Drug Administration and the State Health and Family Planning Commission (March 23) jointly announced the "Medical Device Clinical Trial Quality Management Regulations" (hereinafter referred to as the "Regulations").
The Code will come into force on June 1, 2016. The "Regulations on Clinical Trials of Medical Devices" (hereinafter referred to as the "Regulations") issued by the former State Food and Drug Administration in January 2004 shall be abolished at the same time.
Compared with the 2004 version of the "Regulations", the new version of the "Regulations" has added a lot of content, and the number of words alone has increased by a full 10000 words (the "Regulations" only have more than 3900 words, and the "Regulations" have more than 13900 words).
The requirements of the Code are also higher. For example, it is clear that "the development of experimental medical devices should meet the relevant requirements of the applicable medical device quality management system", strengthen the responsibilities and obligations of all parties in clinical trials, and clarify the requirements for the identification, use and disposal of experimental medical devices.
From now on, there are only more than two months left before the "Code" comes into effect, and there is not much time left for enterprises.
Don't forget that as early as the beginning of this year, CFDA Director Bi Jingquan revealed in his speech that the key tasks in 2016 include: organizing supervision and spot checks on the authenticity, integrity and compliance of medical device clinical trial data; and starting medical device clinical data verification in due course.
On March 10, the Beijing Municipal Food and Drug Administration issued a notice requiring medical device companies within their jurisdiction to start self-examination of clinical trials. Beijing's move is believed to have fired the first shot at self-examination and verification of clinical trials.
Now that the "Code" is officially promulgated, it is foreseeable that the national medical device clinical trial self-examination and on-site verification work will soon start.
Let's take a look at the verification storm of the authenticity of drug clinical trial data set off in July last year. It has not been completely over yet. As of February 22, 2016, 1136 enterprises had voluntarily withdrawn, accounting for 79% of the total number of self-examination and verification, and 1184 enterprises had withdrawn and failed, accounting for 83% of the total number of self-examination and verification.
With such a high probability of withdrawal and being shot, it can be seen that CFDA is serious about falsifying drug clinical trial data, and medical devices are no exception.
Therefore, enterprises should study the full text of the "Code" as soon as possible. Don't plant it on it and affect the registration application of their own products.
It should be noted that although the "Code" does not apply to in vitro diagnostic reagents managed in accordance with medical devices, relevant companies should not take it lightly. Don't forget the fraud case announced by the CFDA on February 27.
"The registration application for the hepatitis B virus core-related antigen (HBcrAg) test kit of Fuji Ruiou Co., Ltd. was rejected because of the authenticity of the clinical trial data found during the inspection."
This is the living evidence of CFDA's crackdown on fraud and not forgetting in vitro diagnostic reagent enterprises!
Because the full text of the Code is too long, Chinese medical devices are not added to this text. If you want to see the full text, you can click "read the original text" at the end of the article and jump to the original link of CFDA website.
However, Chinese medical devices are also compared to the original "Regulations", the most important changes will be interpreted as follows.
The main differences between the "Code" and the old version of the "Regulations"
1. In the general provisions, the "specification" added "guarantee the standardization of clinical trial process of medical devices", and the results were "scientific and traceable".
2. The "Code" clarifies that the drug regulatory department at or above the provincial level is responsible for the supervision and management of clinical trials of medical devices. Health and family planning authorities to strengthen management within the scope of their duties.
3, the "specification" canceled the "medical device clinical trials of medical devices into clinical trials and medical device clinical verification" requirements.
However, for new products that have not been approved for marketing at home and abroad, and whose performance has not been proven by medicine, the Code stipulates that the design of clinical trial programs should first conduct small sample feasibility tests, and then carry out larger sample effectiveness tests according to the circumstances.
4, the preparation work before clinical trials requires more detailed and strict.
For example: "qualified inspection agencies issued by the product registration inspection report", the time limit within one year.
"Clinical trials should be approved by the ethics committee of the medical device clinical trial institution."
5, on the filing and approval.
The "Code" makes it clear that before the start of clinical trials of medical devices, the applicant shall file with the local provincial drug regulatory department.
Added "for the third class of medical devices listed in the list of clinical trial approval, the clinical trial must be approved by CFDA before implementation".
Deleted "the third type of medical devices implanted in the body or made by borrowing the theory of traditional Chinese medicine that have not yet appeared on the market, the clinical trial plan shall be filed with the medical device technical review agency".
6. Added the qualification requirements for medical device clinical trial institutions. Relevant qualification management measures will be separately formulated by CFDA in conjunction with the Health Planning Commission.
7. The "Code" clarifies that "the development of medical devices for testing shall comply with the relevant requirements of the applicable medical device quality management system".
8, strengthen the protection of the rights and interests of the subjects.
For example, it is clear that the subject "does not bear any financial responsibility" regardless of the withdrawal at any stage ".
A new provision has been added to protect the right to informed consent for minors, people with intellectual disabilities, and critically ill patients as subjects.
The terms of the informed consent form are more, and the source of funding for the trial, possible conflicts of interest, etc.
9. The "Code" newly proposes the concept of multi-center clinical trials, and puts forward a number of specific requirements for its program design and implementation.
10. The composition, responsibilities and review requirements of the ethics committee are clarified. Add "review of the scientific nature of the clinical trial" and give it the right to "suspend or terminate an approved clinical trial at any time.
11. The "Code" clearly states that "the sponsor is responsible for the authenticity and reliability of clinical trials". The old version of the "Regulations" is "clinical practice institutions and researchers are responsible for the correctness and reliability of clinical trial reports".
Add "the sponsor shall not exaggerate the mechanism and efficacy of the experimental medical device in the formulation of the clinical trial program".
The notice period for the sponsor to suspend or terminate the clinical trial should be within 55 days.
12. The Code newly introduces the concept of device defects and specifies in detail the procedures for handling and reporting device defects that occur in clinical trials of medical devices and may lead to serious adverse events.
13. It is limited that clinical trial researchers must have "relevant professional titles and qualifications above deputy senior level" and have the ability to deal with adverse events.
Clarify the responsibilities of clinical trial institutions and researchers before, during and after the trial. For example, a new "clinical trial institutions and researchers shall report to the drug administration department if the sponsor violates relevant regulations or requests to change the test data and conclusions."
14. For the writing of clinical trial reports, new items such as "Ethical Description" and "Personnel List" have been added.
15. A large number of new regulations have been added to the recording of clinical trials.
"Clinical trial institutions, investigators and sponsors shall accurately and completely record the relevant information in clinical trials. And clinical trial records shall be used as original data and shall not be changed at will."
15. A new chapter on the management of medical devices for testing has been added to the Code.
The applicant shall refer to the regulations of the State Food and Drug Administration on the management of medical device instructions and labels, make appropriate marks for the medical devices used in the trial, and mark "test use".
16. A new chapter on basic document management has been added and the retention period of documents has been significantly extended.
The old version of the "Regulations": medical institutions should keep clinical trial data until five years after the termination of the trial. The implementer shall keep the clinical trial data until ten years after the final product is put into use.
The new version of the "standard": clinical trial institutions should keep clinical trial data for 10 years after the end of clinical trials. The sponsor shall keep the clinical trial data until the medical device is not used.
Article Source: CFDA
Finishing: Chinese Medical Devices
